Children affected with Inflammatory Bowel Disease (IBD) might benefit from granulocytapheresis, an experimental technique currently being used in adults. Hospital San Juan de Dios in Barcelona has treated the first paediatric case in Spain. The patient, a 13 year old girl with Crohn’s disease, who was refractory to all other conventional therapies, was included in a multicentre clinical trial that is investigating the feasibility of the treatment in paediatric patients. The girl has a five year history of Crohn’s disease and as treated above was refractory to all current Crohn’s disease treatments (including corticosteroids and infliximab), dependent on steroids, with 15 relapses within the last three years.

The first granulocytapheresis treatment took place in Hospital San Juan de Dios in Barcelona, on Wednesday, October 1st, as reported by the gastroenterologist Dr. Vicente Varea.

The girl is the first patient enrolled in a multicentre clinical trial that will include a total of ten cases. This trial will have the support of the Japanese company Otsuka Pharmaceutical s. a., who manufactures the system. Dr. Varea (from Hospital San Juan de Dios) will coordinate the trial, and several Spanish hospitals will also participate in the trial. The other paediatric gastroenterologists involved in this trial are: Pedro Vilar, Javier Martín and Vincent Varea, from Hospital San Juan de Dios (Barcelona); Carmen Ribes, from Hospital La Fe (Valencia); Dolores Gracía Novo, from Hospital Niño Jesús (Madrid); and Gerardo Prieto from Hospital La Paz (Madrid).

Dr. Varea explained, the aim of the work is to investigate if granulocytapheresis (treatment that has been used in adults in Europe for the last three years) might be a real therapeutic alternative for children who do not respond to the conventional treatments and who are steroid resistant. Dr. Varea has detailed the inclusion criteria for this trial: weight > 30Kg, steroid dependent, Crohn’s and/or ulcerative colitis patient who have not responded to standard therapies.

The treatment consists of an apheresis procedure with direct vein-to-vein (contralateral arms) extracorporeal circulation. The speed of the extracorporeal blood flow is 30 ml/min, and in an hour (duration of each apheresis session) a total of 1800 ml of blood are circulated. The procedure selectively removes granulocytes and monocytes/macrophages from the blood of the patient. After the blood is returned to the patient it has been shown that the circulating levels of granulocytes and monocytes/macrophages recover to pre-apheresis levels within three hours.

Experience with granulocytapheresis is still relatively limited in Spain. Dr. Varea said, to be able to make conclusive judgments on granulocytapheresis a lot more patients need to be treated than have been treated in the last three years; however, from a theoretical perspective (based on experience in Spanish and Japanese adults), the procedure might be useful in delaying time to relapse to adult two years, as well as allowing reduction in doses of steroids that the patient is using.

A complete Adacolumn granulocytapheresis treatment consists if one apheresis session a week for five weeks. Patients should undergo usual controls after the treatment.

The benefits
Dr. Vicente Varea has pointed out that the working hypothesis of the trial is to assess whether this technique may constitute, along with minimal maintenance doses, an alternative to treat the acute phase of the pathology as well as the relapse episodes. “We want to achieve the remission and to reduce the doses of medication, as the anti-TNF and steroids”.

Increasing incidence of this pathology in childhood
A significant increase in the incidence of the inflammatory bowel disease has been observed in paediatric patients and in young adults in the last six years. According to Dr. Vicente Varea, every two months a new patient with this pathology arrives to Hospital San Juan de Dios. Moreover, it should be noted that there has been a noticeable decrease in the age of the affected paediatric patients, since the hospital recently diagnosed a-one year-old baby with this illness. The reasons for these increases are still unclear but the trends seen in Spain are coming more and more closer to the existing higher incidence in Northern Europe countries. Dr. Varea suggested the growth of the incidence in last five or six years of IBD is replacing cases of infectious diarrhoea in paediatric patients (similar trends were seen in Northern European countries). Experts agree that the relationship of environmental and nutritional factors with these trend changes warrant deeper investigation. While these areas are being investigated granulocytapheresis offers a potential realistic treatment option for the most serious cases of IBD.

The trial has obtained approval from the Ethics Committees of the involved centres. Patients accepted to the trial must sign/or have a parent/guardian sign an Informed Consent and watch an informative videotape.